EUDAMED last updated this device on Jul 28, 2026

ESTER

B-08033860016869

On the marketClass IIa

Applicable legislation: —
Organization name: BIOPSYBELL SRL
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 08033860016869
Reference / catalog number: GUN2010EC

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

ESTER is an EU-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by BIOPSYBELL SRL. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: ESTER
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 08033860016869
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: B-08033860016869
Reference / catalog number: GUN2010EC
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Classification

Risk category: Class IIa
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08033860016869

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

A0102010102SHEARING BIOPSY GUNS

Critical warnings

6 warnings recorded — scroll inside the panel to see all entries.

Caution
Consult instructions for use
Do not re-use
Do not resterilize
Do not use if package is damaged
Do not use past indicated date

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Italy; available across 8 countries total.

Country	On market since	Until
ItalyPrimary placement	—	Still on market
Bulgaria	—	Still on market
Cyprus	—	Still on market
Germany	—	Still on market
Spain	—	Still on market
France	—	Still on market
Ireland	—	Still on market
Portugal	—	Still on market

Related searches

Class IIa medical devices in EUDAMED

Device identification

Trade name: ESTER
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 08033860016869
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: B-08033860016869
Reference / catalog number: GUN2010EC
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Certificates

Certificate health across this manufacturer's portfolio.

IT349638Issued
Quality assurance
Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
: BUREAU VERITAS ITALIA S.P.A. (1370)Expiry: Feb 9, 2030

Market distribution

Primary placement in Italy; available across 8 countries total.

Country	On market since	Until
ItalyPrimary placement	—	Still on market
Bulgaria	—	Still on market
Cyprus	—	Still on market
Germany	—	Still on market
Spain	—	Still on market
France	—	Still on market
Ireland	—	Still on market
Portugal	—	Still on market

ESTER

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Legacy certificates

Certificates covering this device

Related devices

Market distribution

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Manufacturer information

Certificates

Legacy certificates

Related devices

Certificates covering this device